Flexible non-contact wound treatment device with a single joint

ABSTRACT

A non-contact wound treatment device suitable for releasable attachment to a patient&#39;s skin surface over a selected wound area in a non-contact position relative to the selected wound area, the wound treatment device comprising an attachment portion suitable for releasable attachment with the patient&#39;s skin surface, having an inner perimeter for defining the selected wound area, a wound treatment portion with a wound cover and a support member supporting the wound cover, and a transition portion with a joint connecting the wound treatment portion to the attachment portion.

CROSS REFERENCE TO RELATED CASES

This application is a continutation of Ser. No. 08/843,072 filed Apr.11, 1997, which is a Continuation-in-Part of U.S. patent applicationSer. No. 08/342,741, filed Nov. 21, 1994 now U.S. Pat. No. 5,817,145titled WOUND TREATMENT DEVICE, assigned commonly with this application.

This application contains material related to the U.S. Patentapplication filed on even date herewith that is entitled “FLEXIBLENON-CONTACT WOUND TREATMENT DEVICE” and to the following pending U.S.Patent applications all assigned commonly with this application:

Ser. No. 07/900,656, filed Jun. 19, 1992, for “THERMAL BODY TREATMENTAPPARATUS AND METHOD”;

Ser. No. 08/356,325, filed Feb. 21, 1995, for “WOUND COVERING”;

Ser. No. 08/785,794, filed Jan. 21, 1997, for “NORMOTHERMIC HEATER WOUNDCOVERING”;

Ser. No. 08/86,713, filed Jan. 21, 1997, for “NORMOTHERMIC TISSUEHEATING WOUND COVERING”;

Ser. No. 08/786,714, filed Jan. 21, 1997, for “NEAR HYPOTHERMIC HEATERWOUND COVERING”.

Technical Field

This invention relates to a wound treatment device and, in particular,to a wound treatment device having a substantial portion of a woundcover that is in non-contact with a wound and capable of delivering heatto the wound. More particularly, the wound treatment device includessuch a wound treatment device with a single joint that maximizes theability of the wound treatment device to adapt to the contours andmovements of a human body.

BACKGROUND OF THE INVENTION

A novel mode of wound treatment is disclosed in detail in published PCTApplications WO 94/00090 and WO 96/15745, both owned in common with thisapplication. This new treatment employs a non-contact wound treatmentdevice that covers a wound, forming a treatment volume about and overthe wound. An embodiment of such a wound treatment device may becharacterized in having a plurality of parts, three of which are usefulfor the purpose of description. These. three parts are an attachmentportion, a wound treatment portion, and a transition portion. Eachportion serves a respective function.

The attachment portion connects and retains the wound treatment deviceon the skin of a person. The wound treatment portion typically includesa standoff that rises above the person's skin surface, and a wound coverthat spans an open portion of the standoff. Together, the standoff andwound cover define a wound treatment volume and a wound treatment areaonto which the wound treatment volume is projected.

The transition portion connects the attachment portion to the woundtreatment portion. An important function of the transition portion is toadapt the wound treatment device to the contour of the portion of aperson's body where the device is mounted and to movements of theperson's body that deform the wound treatment device in situ. In thisregard, an important function of the transition portion is theaccommodation of patient motion by the compliance of the transitionportion.

Achievement of this important function of the transition portion ischallenged by the need to maintain the orientation of the wound cover inthe wound treatment portion —both in aspect and location —with respectto the wound being treated. The orientation of the wound cover isdifficult to maintain when the wound treatment device is mounted on ahighly curved part of a body. While the wound treatment devicesdisclosed in the referenced PCT applications exhibit excellentadaptability in a surface that is parallel to the surface of the bodyportion where the wound treatment device is mounted, there is impairmentof adaptability and disturbance of the orientation of the wound coverdue to limited flexibility in the direction of a Z axis that isperpendicular to the surfaces. If the transition portion issubstantially perpendicular to the attachment portion, it may buckle inresponse to body motion or contour and collapse the standoff in thewound treatment portion. The collapse of the standoff of course altersthe orientation of the wound cover with respect to the wound, possiblyreducing the effectiveness of the wound treatment device.

Z axis conformability is especially important for a wound treatmentdevice used on a portion of a person's lower leg. The lower leg has avery tight radius of curvature. Therefore, when a three-dimensionalwound treatment device is curved around a lower leg, substantial stressresults that may result in deformation of the shape of the woundtreatment device, in some cases even causing the wound cover to contactthe wound.

SUMMARY OF THE INVENTION

The overall flexibility of a wound treatment device is enhanced by aninvention based upon the inventors'critical realization that provisionof a joint in the transition portion that connects the wound treatmentportion to the attachment portion accommodates patient motion andcontour by providing articulation between these portions that permitsflexion of the wound treatment device in all dimensions of the volumethat the wound treatment device occupies.

In this invention, the joint connects the wound treatment portion to theattachment portion, extending between the standoff and the attachmentportion. The joint attaches to the attachment portion under the standoffbetween inner and outer perimeters of the attachment portion.

Preferably, the inner perimeter of the attachment portion is limited tobeing contained within the outer perimeter of the standoff. This permitsreduction of the size of the attachment portion, minimizing the total“foot print” of the wound treatment device. A smaller footprint isgenerally considered to be advantageous particularly when attaching thewound treatment device to a highly curved part of a person's body, suchas the surface of a lower leg.

The joint, its connection of the standoff with the attach mnent portion,and its attachment to the attachment portion between inner and outerperimeters of the attachment portion provides a hinge-like operationthat maximizes the adaptability of the wound treatment device andmaintains the orientation of the wound cover over greater ranges of bodycurvature and movement than previously obtainable.

It is, accordingly, an objective of this invention to provide aflexible, non-contact wound treatment device that adapts to bodycurvature and motion.

Another objective is the provision of a non-contact wound treatmentdevice having a wound treatment portion and an attachment portion, witha joint between the wound treatment and attachment portions.

It is a related objective in this latter regard to provide a jointbetween the wound treatment and attachment portions in the form of anaccordion- or bellows-like member operating between the bottom of thestandoff in the wound treatment portion and the attachment portion.

It is a further related objective to provide a joint between the woundtreatment and attachment portions in the form of a seam joining theseportions and permitting articulation therebetween.

A significant advantage of the invention is the potential reduction insize of the attachment portion, providing a smaller footprint of thewound treatment device.

BRIEF DESCRIPTION OF THE DRAWINGS

The various figures of the drawing depict illustrative and exemplaryforms of the wound treatment device. Throughout the several views,identical reference characters represent similar or equivalentstructures wherein:

FIG. 1 is a perspective view of one embodiment of the wound treatmentdevice;

FIG. 2 is a schematic view of projected areas;

FIG. 3 is a schematic view of projected areas;

FIG. 4 is a perspective view of a detachable heater in combination withthe one embodiment of a wound treatment device;

FIG. 5 is an exploded view of the one embodiment of a wound treatmentdevice;

FIG. 6 is an exploded view of another embodiment of a wound treatmentdevice;

FIG. 7 is a perspective view of a heater system;

FIG. 8 is an electrical schematic of a pressure sensitive switch for aheater system;

FIG. 9A is an exploded view of a pressure sensitive switch incorporatedinto a wound treatment device;

FIG. 9B is a view of a portion of the pressure sensitive switch;

FIG. 10 is a perspective view of a passive heater embodiment of thewound treatment device;

FIG. 11A is a schematic drawing depicting an alternate geometry for thetransition portion;

FIG. 11B is a schematic drawing depicting an alternate geometry for thetransition portion;

FIG. 11C is a schematic drawing depicting an alternate geometry for thetransition portion;

FIG. 11D is a schematic drawing depicting an alternate geometry for thetransition portion;

FIG. 12A is a schematic drawing depicting functional relationshipsbetween several elements of the invention;

FIG. 12B is a schematic drawing depicting functional relationshipsbetween several elements of the invention;

FIG. 13A is a schematic drawing depicting functional relationshipsbetween several elements of the invention;

FIG. 13B is a schematic drawing depicting functional relationshipsbetween several elements of the invention;

FIG. 14A is a schematic drawing depicting functional relationshipsbetween several elements of the invention;

FIG. 14B is a schematic drawing depicting functional relationshipsbetween several elements of the invention;

FIG. 15 is a perspective view of an embodiment of a flexible non-contactwound treatment device;

FIG. 16 is a perspective view of a detachable heater in combination withthe embodiment of FIG. 15;

FIG. 17 is an exploded view of the embodiment of FIG. 15;

FIG. 18A is a cross-sectional perspective view of the embodiment of theFIG. 15 referred to A—A in FIG. 15;

FIG. 18B is a cross-sectional perspective view of the embodiment of FIG.15 showing the operation of a membrane in adapting the wound treatmentdevice to body motion referred to A—A in FIG. 15;

FIG. 18C is a magnified partial cross-sectional view of the embodimentof FIG. 15 showing further operation of the membrane in accommodatingbody motion;

FIG. 19A is a side elevational view of the cross-sectional view of FIG.18B when attached to a human patient;

FIG. 19B is a side elevational view representing the cross-sectionalview of FIG. 18C;

FIG. 20 is a perspective view of our invention, embodied as a flexiblenon-contact wound treatment device with a single flexion joint;

FIG. 21 is a cross-sectional perspective view of a first preferredembodiment referred to A—A in FIG. 20;

FIG. 22 is an exploded view of the cross-sectional illustration of thefirst embodiment;

FIG. 23 is a cross-sectional side view of the first embodiment, whenattached to a human patient;

FIG. 24 is a cross-sectional perspective view of a second embodimentreferred to in A—A in FIG. 20;

FIG. 25 is an exploded cross-sectional view of the second embodiment;and

FIGS. 26A, B, and C are cross-sectional side views of the secondembodiment when attached to a human patient;

FIG. 27 is perspective view of a third preferred embodiment;

FIG. 28 is a cross-sectional perspective view of a third preferredembodiment referenced to B—B in FIG. 27; and

FIG. 29 is a cross-sectional side view of the third embodiment.

DETAILED DESCRIPTION

For an understanding of the invention that is disclosed and claimed inthis application, reference is made to FIGS. 1-10 in which embodimentsand elements of a wound treatment device are illustrated. With referenceespecially to FIG. 1, a wound treatment device 10 has a planar uppersurface displaced above the skin surface of the patient or person havinga wound that is being treated by application and operation of the device10. The wound treatment device 10 further includes an attachment surfacegenerally held in a plane or surface that is coincident with the planeor surface of the person's skin. Together these two surfaces define anenclosed, non-contact volume over a wound treatment site.

The wound treatment device 10 that is illustrated in FIG. 1 may beconsidered in a general way for the purpose of description. In thisregard, the description of a wound treatment device is aided byconsidering three separate parts of the wound treatment device 10. Theseparts are an attachment portion 12, a wound treatment portion 14, and atransition portion 16. Each portion is designed to serve a separate function.

The attachment portion 12 is used to connect the wound treatment device10 to the skin of a patient. The wound treatment portion 14 of the woundtreatment device 10 defines a vertical extent or dimension of the woundtreatment device 10, and thus defines the location of the attachmentsurface. The transition portion 16 connects the attachment portion 12 tothe wound treatment portion 14. The transition portion 16 is provided toimprove the comfort and utility of the wound treatment device 10 whenthe patient moves and stretches the device.

FIG. 1 is a perspective view of a wound treatment device 10 applied to apatient's skin surface 18. A coordinate system 11 is depicted on thepatient's skin surface 18 and it defines X, Y and Z directions. Anattachment portion 12 is formed as an planar rim or flange. Thisattachment portion 12 is attached to the patient's skin 18 with anadhesive and it lies in a first XY plane. In this embodiment of woundtreatment device 10, a transition portion 16 is integrally formed withattachment portion 12. Transition portion 16 rises from the skin surfacein the Z direction to connect to a wound treatment portion 14. In thisembodiment, wound treatment portion 14 has a transparent planar woundcover 20 which allows one to see a wound treatment area 28. Wound cover20 is supported above the first XY plane by a foam ring standoff 15.Wound cover 20 lies in a second XY plane that is vertically displacedalong the Z-axis by foam ring standoff 15 from the first XY plane. Woundcover 20 and foam ring standoff 15 together form wound treatment portion14. The region over wound treatment area 28 is called a wound treatmentvolume 24.

In this figure, wound treatment device 10 has been applied to apatient's skin and is in a relaxed state. In this unstressed state onecan see an outer periphery 22 of attachment portion 12. An innerperiphery 23 is shown by a crease in the structure where it connects totransition portion 16.

FIG. 2 and FIG. 3 should be considered together where they show theinfluence of patient motion on wound treatment device 10. Both FIG. 2and FIG. 3 are top views of wound treatment device 10 of FIG. 1 with thevarious portions of wound treatment device 10 projected onto the firstXY plane.

In FIG. 2, the wound covering is shown in a relaxed and un-stretchedstate having a nominal total projected area 27. Projected woundtreatment area 28 is shown at the center of the wound treatment device10. The outline of foam ring standoff 15 may be seen as the crosshatcharea bounded by an exterior perimeter 25 of foam ring standoff 15, andan interior perimeter 26 of foam ring standoff 15. A transition portionprojected area 17 is bounded by inner periphery 23 of attachment portion12, and interior perimeter 26 of foam ring standoff 15. An attachmentportion projected area 40 is shown as that cross hatched area bounded byouter periphery 22 and inner periphery 23 of attachment portion 12.

FIG. 3 shows wound treatment device 10 stretched along the X-axis bypatient motion. In comparison to FIG. 2, the overall or total projectedarea 27 of wound treatment device 10 has increased. Attachment portionprojected area 40 has increased slightly as attachment portion 12 moveswith the underlying skin. Projected wound enclosure area 28 isessentially unchanged in area since in this embodiment foam ringstandoff 15 is free move against the skin. The largest percentage areachange occurs in transition portion projected area 17. As woundtreatment device 10 deforms in response to patient motion, transitionportion 16 is compliant and pays out material permitting the majority ofthe increase in total projected area 27 to be accommodated primarily bytransition portion projected area 17.

FIG. 4 shows a detachable heater 32 positioned for insertion into apocket formed by pocket cover 21. Pocket cover 21 is bonded to woundcover 20 and is sized to retain heater 32. Foam ring standoff 15 andwound cover 20 serve to stabilize the shape of wound treatment device 10while transition portion 16 accommodates patient motion. Consequently,heater 32 is reliably and comfortably positioned above the woundsurface. In general, it is desirable to use a planar heater as heater 32which has a prescribed heat output per unit area. This form of heaterresults in a more uniform flux of radiant energy applied to the wound.The amount of heat supplied to the wound area is largely independent ofthe height of heater 32 above the wound surface within the range offinctional heights of this device. In some cases, non-uniform wound areaheating might be desirable and therefore the watt density of the heatermay be non-uniform across its surface.

FIG. 5 is an exploded view of the first embodiment of wound treatmentdevice 10. Attachment portion 12 and transition portion membrane 36 areformed as a unitary composite shell 38. Composite shell 38 may be vacuumformed from closed cell polyolefin foams such as Volara-6AS, which is apolyethylene material as sold by Illbruck Inc., of Minneapolis, Minn. Itshould be apparent that many other materials may be substituted withinthe scope of the invention. Foam ring standoff 15 may be die cut fromfoam sheeting of a reticulated polyurethane foam. The absorbency of thefoam as well as its mechanical properties can be tailored to theparticular wound treatment application. For example, the foam standoffmay be impregnated with a medicament such as an antibiotic, antifungal,or antimicrobial material. It may also be desirable to supply adeodorant material or nitric oxide releasing material from the foamstandoff. Wound cover 20 and wound pocket 21 may be made from a thinfilm of polyethylene. In general, the composite shell should besufficiently self supporting so that when wound treatment device 10 isremoved from its release liner, wound treatment portion 14 is held up orsupported by the shaped flexion joint of transition portion membrane 36,and some effort is required to evert composite shell 38 and turn itinside out This behavior defines the self supporting feature whichcauses foam ring standoff 15 to lie gently against the skin even whenwound treatment device 10 is upside down. For larger wound coverings itmay be desirable to apply a tacky adhesive to the patient contactsurface of the standoff.

FIG. 6 is an exploded view of another embodiment of wound treatmentdevice 10. Attachment portion 12 and transition portion membrane 36 areformed as a unitary composite shell 38. In this embodiment, the woundtreatment volume is defined by a serrated cup standoff 34. Standoff 34may be made from a more rigid polymeric material, such as polyethylene,or the like. The serrations typified by a plurality of serrations 44permit serrated cup standoff 34 to flex and accommodate patient motion.This embodiment shows a release liner 42 coupled to attachment portion12 of composite shell 38 with an adhesive 46. In this embodiment, pocketcover 21 is bonded to composite shell 38.

FIG. 7 depicts a portable power supply 48 to provide for the ambulatoryuse of the heated versions of the wound treatment device. A collectionof battery cells may be wired together to form power supply 48 which maybe conveniently attached to a belt 49. A suitable cable 50 may be usedto conduct power to heater 32. In many instances, it may be desirable tocut off power to heater 32 if wound treatment device 10 is collapsedagainst the wound so as to prevent overheating of the wound surface.

FIG. 8 shows a schematic representation of a touch switch 52 which maybe incorporated directly into detachable heater 32. Heater 32 includes acontinuous resistive heating coil 51. A conductive membrane makes uptouch switch 52 and is arranged near heating coil 51 so that it may“short out” segments or portions of coil 51 it touches. In use, allpower to heating coil 51 is completely turned off by pressure applied toan entire touch sensor 53.

FIG. 9A shows an exploded version of heater 32 incorporating a touchswitch 52 of the type described schematically in FIG. 8. A switch cover45 has a conductive membrane which is located over the conductivepattern of heating coil 51. It is held in position with an adhesive band54. FIG. 9B shows the underside of switch cover 45 showing a pluralityof discrete insulation bumps typified by a bump 47 which serve to spaceand support touch switch 52 above heating coil pattern 51. Pressuresupplied to switch cover 45 inactivates heater coil 51.

FIG. 10 shows an accessory device 55 or cover. This may take the form ofa passive heater (or insulator) with a reflective surface facing thewound. Accessory device 55 may also take the form of a mapping gridwhere a grid work of lines is positioned on a transparent card to permittracking of the wound healing process.

FIG. 11A through FIG. 11D should be considered together. These drawingsfacilitate a description of the connection of the various structures ofthe invention and represent several alternative connection geometries.In general, to accommodate patient motion, the transition portion paysout stored material to increase the projected area of the transitionportion. Each of these drawings represents a mechanical schematic crosssection of a wound treatment device 10 in the XZ plane. In each FIGURE,the wound covering is in the relaxed state.

FIG. 11A shows a schematic view of a ring standoff 15 extending from afirst plane 56 to a second plane 58. Transition portion 16 has atransition portion membrane 60 which is coupled to attachment portion 12by a first flexible connection 62 formed at the intersection ofattachment portion 12 and transition portion 16. Transition portionmembrane 60 is connected to treatment portion 14 at a second flexibleconnection 64 which is formed at the intersection of transition portion16 and wound treatment portion 14. Wound treatment portion 14 isgenerally a cylindrical cup-shaped structure defining a wound treatmentarea on the patient skin surface. A minimum interconnection distance 66is depicted as a dashed line extending from first flexible connection 62to second flexible connection 64. The length of minimum interconnectiondistance 66 can be used to characterize the “length” of transitionportion membrane 60. For many embodiments of the invention, the lengthof transition portion 16 between first flexible connection 62 and secondflexible connection 64 is greater than the length of the straight linedrawn between these points. This relationship is true for manyembodiments of the wound treatment device when they are in the relaxedor unstressed position. It should be noted that the vertical distancebetween first plane 56 and second plane 58 represents a minimum valuefor minimum interconnection distance 66. In the XY plane, first flexibleconnection 62 forms a first perimeter 61 and a second perimeter 63. Inthe embodiment depicted in FIG. 11A, first perimeter 61 is larger thansecond perimeter 63.

FIG. 11B is a mechanical schematic diagram which represents a crosssection of another embodiment of the wound treatment device 10 with analternate connection geometry. In this drawing, wound cover 20 extendsradially beyond wound treatment volume 24 so that a second perimeter 68is greater than a first perimeter 71. This generates a reflex transitionportion 74 construction which may be adopted to increase the “length”and amount of material in the reflex transition portion 74.

FIG. 11C shows a construction where a first perimeter 76 and a secondperimeter 78 have approximately the same value and are both concentricwith an axis 90. This construction can produce an undulated transitionportion 77. Once again, the length of undulated transition portion 77exceeds the length of a line 65 between first perimeter 76 and secondperimeter 78.

FIG. 11D shows a hemispheric shell 70 as wound treatment portion 14. Inthis embodiment a second perimeter 80 is a single line of attachmentthat is generally concentric with axis 90. In this embodiment, a firstperimeter 81 has a length which greatly exceeds the length of secondperimeter 80. This construction forms a hemispheric transition portion79 which has a length which exceeds the linear distance between secondperimeter 80 and first perimeter 81 along a line 85.

Although the various geometries vary in detail, it is preferable to formtransition portion 16 from a resilient material which is generallyself-supporting, yet sufficiently flexible so that it acts as acompliant hinge mechanism. This flexibility substantially limits thetransfer of shearing force from wound treatment portion 14 to attachmentportion 12 of the wound treatment device 10, and visa versa. With thegeometries set forth in FIG. 11A through FIG. 11D, transition portion 16of wound treatment device 10 forms a shaped flexion joint or formedexpansion joint which stores “material” in a pleat, convolution,bellows, or the like. This type of structure provides a means forexpanding the size of transition portion 16 resulting in minimizing thetransfer of forces from attachment portion 12 to wound treatment portion14.

FIG. 12A through FIG. 14B should be considered together. In theseembodiments of the invention, the standoff structure reduces in heightresulting in increased transition portion projected area 17 during thestretching of the wound treatment device.

FIG. 12A shows a part of a wound treatment device having foam ringstandoff 15 in the unstressed or relaxed state. In this instance,transition portion projected area 17 is proportional to a dimension 88.In FIG. 12B, the wound treatment device has been stretched and theheight of foam ring standoff 15 is reduced in the Z direction which hasincreased transition portion projected area 17 as represented bydimension 91.

FIG. 13A shows a part of a wound treatment device having serrated cupstandoff 34 in the unstressed or relaxed state. In this instance,transition portion projected area 17 is proportional to a dimension 98.In FIG. 13B, the wound treatment device has been stretched, and theheight of serrated cup standoff 34 is reduced in the Z direction. Theserrated wall sections splay out to permit the height reduction whichincreases transition portion projected area 17 as represented by adimension 99.

FIG. 14A shows a part of a wound treatment device having foam ringstandoff 15 in the unstressed or relaxed state. However, in thisconstruction attachment portion 12 and a transition portion membrane 96lie entirely in first plane 56. In this instance, transition portionprojected area 17 is proportional to a dimension 94. In FIG. 14B, thewound treatment device has been stretched and the height of the foamring standoff 15 is reduced in the Z direction. This height reductionincreases transition portion projected area 17 represented by adimension 92.

A flexible, non-contact wound treatment device is illustrated in FIGS.15-19B where the same reference numerals specify identical partsthroughout the drawings.

FIG. 15 is a perspective view of a flexible, non-contact wound treatmentdevice 100 for application to a patient's skin surface. An attachmentportion 102 is formed as a collar or flange. This attachment portion 102is for attachment around a wound through an adhesive layer on theunderside of the attachment portion. The embodiment of wound treatmentdevice 100 also embraces a wound treatment portion 104 that includes awound cover 105, described below, supported by a support member in theform of a standoff 106. A transition portion 108 connects the woundtreatment portion 104 to the attachment portion 102 and preferablyincludes a membrane 110 that extends around an outer periphery of thesupport member 106 and is attached to the attachment portion 102 betweeninner and outer peripheries thereof.

Referring now to FIGS. 15 and 17, in the wound treatment device 100, theattachment portion 102 is an integrated, unitary assembly preferablyhaving three sections: a foam layer 111, an adhesive film layer 112 on abottom surface of the foam layer 111, and a release liner 113 coveringthe adhesive film layer 112. One or more lines of weakness orperforation 114 are provided on the release liner 113 so that its partsmay be separated and selectably peeled off of the adhesive film layer112, thereby to expose the adhesive film layer 112 a section at a timefor application to a person's skin. The foam layer 111 may comprise anaturally open-celled polyurethane foam. The foam layer 111 ispreferably approximately {fraction (1/8″+L )} thick. The adhesive filmlayer 112 may comprise a high MVTR thin film, pressure sensitiveadhesive (PSA) laminate available as a package under the trade nameMediderm from Bertek. The foam layer 111 is heat bonded to the adhesivefilm layer 112. The material of which the adhesive film layer 112 iscomprised is selected for a combination of adhesion level, permeability,and conformability (stretching and flexing with the skin) to allowprolonged skin contact, without complications. The release liner 113 isa white release paper coated with a release agent that is provided onthe Mediderm 3701 product. The perforations or slits 114 are made duringassembly to aid in the removal of the release liner 113 prior toattachment of a wound treatment device to a person.

When 111, 112 and 113 are assembled, the attachment portion 102 is aflexible collar shaped part with an inner periphery portion 111 i on anupper surface 111 s of the foam layer 111 around an inner perimeter, oredge, 111 e. The upper surface 111 s faces, and is therefore disposedunder, or beneath, the support member 106. The attachment portion 102further includes an outer perimeter, or edge, 111 o.

The wound treatment portion 104 includes the support member 106, whichis preferably a ring of absorbent foam such as a naturally open-celledpolyurethane foam that is selected to have favorable characteristics ofabsorbency, leaking and resevoiring. Such material is available as aproduct sold under the trade name Aquazone from Foamex. The supportmember 106 has an upper surface 107, a lower surface (109 in FIGS.18B-19B), an outer perimeter, or edge, 118 and an inner perimeter, oredge, 119. The thickness of the support member 106 is preferably in arange extending from {fraction (1/2″+L )} to {fraction (5/8″+L )}, withthe exact dimension being selected to maintain non-contact at woundsites whereby, during use, the foam ring can compress and conformwithout the wound cover contacting the wound. The wound cover 105 in thepreferred embodiment includes a layer 120 preferably of 4 mil.-thickclear, flexible polyurethane film with favorable characteristicsselected, but not limited, to include moisture vapor transfer, oxygenpermeability, and transmission of infrared radiation. Such material isavailable as a product sold under the trade name Deerfield 6100S. Thelayer 120 is attached to the upper surface 107 of the support member 106by a ring 124 of adhesive comprising a synthetic rubber-base adhesivesuch the product sold under the trade name HL-2306-X by H. B. FullerAdhesive. When the layer 120 is attached to the upper surface 107 of thesupport member 106, a perimeter portion 121 of the layer 120 extends outbeyond the outer perimeter 118 of the support member 106. The woundcover 105 further includes a stretcher layer 125 attached to the layer120 so that the layer 120 is sandwiched between the stretcher layer 125and the upper surface 107 of the support member 106. The stretcher layer125 is a 5 mil-thick planar sheet of (preferably) clear, somewhatflexible polyester film having enough stiffness to aid in maintainingplanarity of the wound treatment portion 104. The function of thestretcher layer 125 is to hold the layer 120 taut, much as a “stretcherframe” tautens an artist's canvas. The stretcher layer 125 is attachedto the layer 120 by a layer 126 of adhesive comprising a clear flexiblepolyester carrier film coated on both sides with an aggressive adhesive.The adhesive layer 126 is oriented over the support member 106. A filmcarrier allows for the adhesive to be run in a web process and die cutduring manufacturing of the stretcher layer 125. The stretcher layer 125further includes a pair of slits 128 that receive a detachable heater.With the provision of the slits 128, a pocket is formed between thestretcher layer 125 and the layer 120.

The transition portion 108 includes a lower collar 130 that ispreferably formed from the same material as the layer 120. Thetransition portion 108 also includes the outer perimeter portion 121 ofthe layer 120 that extends out beyond the support member 106 whenassembled thereto. When the wound treatment device 100 is assembled, acircumferential edge 122 of the layer 120 is joined to a correspondingcircumferential edge 132 of the lower collar 130. Preferably, the edges122 and 132 are sealed or welded together by a heat process. When sojoined, the outer perimeter portion 121 of the layer 120 and the lowercollar 130 form the membrane 110, which extends over the outside of theouter perimeter 118 of the support member 106. The lower collar has aring-like shape that includes an inner periphery 131. An inner peripheryportion 133 comprises an annular portion of the lower collar material ona surface of the lower collar that faces away from the lower surface 109of the support member 106. The lower surface 109 is not shown in FIG.17, but may be seen in FIGS. 19A and 19B.

The membrane 110 of the transition portion 108 is attached to theattachment portion 102 by heat-bonding or otherwise connecting the innerperiphery portion 133 of the lower collar 130 at or near the opposinginner periphery portion 111 i of the attachment portion 102.

Many variations of the assembly illustrated in FIGS. 15 and 17 arepossible. For example, the support member 106 could be contained withinthe structure formed by the layer 120, lower collar 130, and attachmentportion 102, unattached to any portion of the structure.

FIG. 16 shows a detachable heater 140 positioned on the wound cover 105within a pocket formed between the layer 120 and the stretcher layer125, with the opening to the pocket provided by one of the slits 128.The wound cover 105, with the heater 140 contained within the pocket, issupported substantially in a plane or surface above a wound by thesupport member 106. The heater 140 is generally planar and may beconnected to and powered by a portable power supply such as thatillustrated in FIG. 7.

Refer now to FIGS. 18-18C in which FIGS. 18A and 18B show details of thewound treatment device 100 when assembled and put in use. FIG. 18Aillustrates the relationship of the attachment portion 102 with respectto the support member 106 of the wound treatment portion 104. In thisregard, when the wound treatment device is assembled and placed on aflat surface, the attachment portion 102 and wound treatment portion 104substantially align along the inner perimeters 119 and 111 e.

The seal between the inner periphery portion 133 of the lower collar 130and the inner periphery portion 111 i of the attachment portion 102 liesbeneath the lower surface of the support member 106. This is the surfacethat is indicated by reference numeral 109 in FIGS. 19A and 19B.Preferably, the seal joining the inner periphery portions 133 and 111 iis a continuous, closed-loop seal. Although, for reasons explainedbelow, this is the preferred location of the seal between the lowercollar 130 and attachment portion 102, the inventors contemplate thatthe seal could comprise a substantially continuous, closed-loop traceanywhere between the outer perimeter 111 o and inner perimeter 111 e ofthe attachment member 102.

In FIGS. 17 and 18A, the seal between the edges 122 and 132 of the layer120 and lower collar 130 is exaggerated as a flange. In practice, theshape of the membrane 110 extending from an upper outer edge 107 ue ofthe upper surface 107 to a lower outer edge 118 be of the outerperimeter 118 is rather elongated, with the flange much less pronouncedthan shown in FIG. 18A. Of course, the membrane 110 in the extent fromthe edge 107 ue all the way down to the seal that joins the innerperiphery portions 133 and 111 i is not attached, and is therefore freefrom, although in close proximity to, the outer perimeter 118, loweredge 118 be and lower surface 109 of the support member 106.

Referring now to FIGS. 18B-19B, the flexible, non-contact woundtreatment device 100 is suitable for placement onto a skin surface 150of a patient or person so as to include a selected wound area 152 thatabuts a treatment volume 156 within the treatment device 100. Thisattachment may be directly to the skin surface 150, or on another membersuch as an ostomy ring that is, in turn, mounted or attached to the skinsurface 150. As FIGS. 18B-19B demonstrate, the flexible, non-contactwound treatment device 100 of this invention satisfies the objectivepreviously stated by a capability of being conformably attached to anuneven, changing surface supporting a wound treatment portion 104 thatremains reasonably or substantially planar in its shape, regardless ofbody contour or movements. In this regard, as FIGS. 18B and 19Billustrate, the attachment portion 102 operates as a hinge or flexionjoint that pivots at the seal between the inner periphery portions 133and 111 i. Relatedly, the attachment portion 102 is free to conform tothe shape of the skin surface by flexibly deforming between the innerand outer perimeters 111 e and 111 o. At the same time, the woundtreatment portion 104 is relatively undeformed so that the supportmember 106 is able to support the layer 120 and stretcher layer 125 in arelatively planar orientation with respect to the wound area 152. In themeantime, the wound treatment device 100 forms a barrier between thewound treatment v6lume 156 and the ambient atmosphere by virtue of theseal between the edges 122 and 132 of the layer 120 and lower collar130, and the seal between the inner periphery portions 133 and 111 i.The bottom of the wound treatment device 100 is sealed to the skin 150when the release layer 113 is peeled off so that the adhesive film layer112 seals to the skin surface 150.

FIGS. 18C and 19B illustrate the conformability of the wound treatmentdevice 100 provided by flexion of the membrane 110 in the transitionportion 108. FIGS. 18C and 19B are “snap shots” of the flexible,non-contact wound treatment device 100 after placement as describedabove with reference to FIGS. 18B and 19A and after movement of a bodypart on which the device 100 is placed. In these figures, movement isaccommodated by excess length in the membrane 110. In FIGS. 18C and 19B,the membrane 110 has tensioned along the perimeter 118 to provide strainrelief between the lower edge 118 be of the support member 106 and theseal between the inner periphery portions 133 and 111 i. In addition,the flexibility of the membrane 110 and its freedom from the outerperimeter 118 and lower surface 109 permit a play out of excess lengthof the membrane 110 that abuts the outer perimeter 118 of the supportmember 106. This moves the membrane 110 into close touching engagementwith the outer perimeter 118, while lengthening the amount of membrane110 available between the lower edge 118be and the inner peripheryportion 111 i.

In another aspect, as FIGS. 18C and 19B show, the membrane 110 acts as adouble hinge or a double pleat between the lower edge 118 be of thesupport member 106 and the attachment portion 102. A first hinge pivotor pleat is at the seal between 133 and 111 i. This hinge permits theattachment portion to pivot toward and away from the wound treatmentportion. The second hinge—at edge 118 be—allows the wound treatmentportion to move toward and away from the attachment portion. Manifestly,the same effect could be achieved by attachment of the membrane 110 tothe lower surface 109 inside of the edge 118 be.

Three significant advantages result from placement of the attachmentportion 102 beneath the support member 106 of the wound treatmentportion.

First, in plan, the shapes and extents of the bottom surface 109 and theattachment portion 102 align and largely overlap, thereby reducing the“foot print” of the wound treatment device 100 to a single,substantially annular shape from the two concentric shapes of FIGS. 2and 3.

Next, the double hinge (or pleat) provided by the membrane 110 increasesthe conformability of the wound treatment device to shape and movement,while maintaining the planarity of the wound cover and preventing itscontact with a wound.

Last, the lower collar 130, in extending substantially to the innerperimeter 111 e of the attachment portion 102 forms a barrier tomoisture and wound exudate which may be absorbed by the support member106, thereby reducing maceration of skin underneath the attachmentportion 102.

The Invention

Our flexible, non-contact wound treatment device with a single joint isillustrated, in perspective, in FIG. 20. A first preferred embodiment ofour invention is illustrated in FIGS. 21-23, a second embodiment isillustrated in FIGS. 24-26A, B and C and a third embodiment isillustrated in FIGS. 27-29. Among these embodiments, identical referencenumerals specify identical parts throughout the drawings.

FIG. 20 is a perspective view of the flexible, non-contact woundtreatment device 200 for application to a patient's skin surface. Anattachment portion 202 is formed as a collar or a flange. Thisattachment portion 202 is for attachment to a patient's skin around awound by way of an adhesive layer on the underside of the attachmentportion. Our preferred embodiment of the wound treatment device 200 alsoembraces a wound treatment portion 204 that includes a wound cover 205,described below, supported by a support member in the form of a standoff206. A transition portion 208 with a single joint, described below withreference to two preferred embodiments, connects the wound treatmentportion 204 to the attachment portion 202.

In a first embodiment, illustrated in FIGS. 21 and 22, the transitionportion 208 comprises a joint embodied as a pleated member 210. Thepleated member 210 comprises multiple stacked pleats so that it assumesan accordion- or bellows-like configuration that operates between alower surface of the standoff 206 and an upper surface 219 of theattachment portion 202.

In a second embodiment illustrated in FIGS. 24, 25 and 26 the transitionportion 208 comprises a single joint in the form of a substantiallycontinuous seam formed by glueing, heat-welding, or any other equivalentand appropriate attachment procedure between the upper surface 219 ofthe attachment portion 202 and the lower surface of the standoff 206.Such a seam may be positioned, as preferred, on the surface 219 betweeninner and outer perimeters of the attachment portion 202. Threeexemplary traces showing the location of the seam with respect to theupper surface 219 are indicated by 208/220, by 208/221, and by 208/222.

In a third embodiment, illustrated in FIGS. 27-29, the transitionportion 208 comprises a “living hinge” in the form of a narrow bridge209 of foam material in a preferably continuous annulus that spans andprovides a hinge between attachment portion 202 and the lower surface ofthe standoff 206. Such a bridge may be positioned, as preferred, betweenthe attachment portion 202 and the standoff 206 within the inner andouter perimeters of the attachment portion 202. Although only a singleexemplary location of the bridge is shown, it is to be understood thatmany other locations would also be possible.

Referring now to FIGS. 22 and 25, in the wound treatment device 200, theattachment portion 202 is an integrated, unitary assembly preferablyhaving the three sections, the properties, and the operations describedabove with reference to FIGS. 15 and 17. In this regard, the attachmentportion 202 is a flexible, collar-shaped part with an inner perimeter222 and an outer perimeter 223. The upper surface 219 of the attachmentmember 202 faces, and therefore is disposed under, or beneath, thesupport member 206, facing its lower surface.

The wound treatment portion 204 includes a support member preferably inthe form of the standoff 206, which is preferably a ring of absorbentfoam. Such foam may comprise, for example, naturally open-celledpolyurethane foam that is selected to have favorable characteristics ofabsorbency, leaking and resevoiring. Preferably, the foam may be of thetype known as “self-skinning foam.” Such material is available asproducts sold under the trade names Aquazone and P100Z, from Foamex.Typically, self-skinning foam forms a non-permeable skin when molded.Thus the upper surface 225, the outer surface 226, and the lower surfaceof the standoff 206 (not shown, but oppositely-directed from the uppersurface 225) are “skinned”, while the center of the standoff 206 is diecut to expose the open cell structure on the inner surface 227. Thus,the inner surface 227 has the desirable property of absorbency (amongothers) described above with reference to the standoff of the woundtreatment devices illustrated in FIGS. 1-19. The thickness of thestandoff 206 is preferably in a range extending from {fraction (1/2″+L)} to {fraction (5/8″+L )}, with the exact dimension being selected tomaintain non-contact at wound sites whereby, during use, the standoff206 can compress and conform without the wound cover contacting thewound. Alternatively, if a high moisture-vapor transission rate (MVTR)is desirable, the outer surface 226 may also be die cut exposing theopen cells of the foam to the environment. Further, the standoff 206 maybe altogether skinless if required.

The wound cover 205 includes a layer 230 preferably of 4 mil.-thickclear, flexible polyurethane film with favorable characteristicsselected, but not limited, to include moisture vapor transfer, oxygenpermeability, and transmission of infrared radiation. Such material isavailable as a product sold under the name Deerfield 6100S. The layer230 is attached to the upper surface 225 of the support member 206 by aring of adhesive (not shown) comprising a synthetic rubber-basedadhesive such as the product sold under the trade name HL-2306X by H. B.Fuller Adhesive. When the layer 230 is attached to the upper surface 225of the support member 206, its edge or perimeter is substantially flushwith the edge or perimeter formed in the upper surface 225 by the outersurface 226. The wound cover 205 further includes a stretcher layer 232attached to the layer 230 so that the layer 230 is sandwiched betweenthe stretcher layer 232 and the upper surface 225 of the standoff 206.The stretcher layer 232 is preferably a 5 mil.-thick planar sheet of(preferably) clear, somewhat flexible polyester film having enoughstiffness to aid in maintaining planarity of the wound treatment portion204. The function of the stretcher layer 232 is to hold the layer 230taut, much as a “stretcher frame” tautens an artist's canvas. Thestretcher layer 232 is attached to the layer 230 by a layer of adhesive(not shown) comprising a clear flexible polyester carrier film coated onboth sides with an aggressive adhesive. The stretcher layer 232 furtherincludes a pair of slits 233 that receive a detachable heater. With theprovision of the slits 233, a pocket is formed between the stretcherlayer 232 and the layer 230.

Many variations of the materials and shapes of the elements thus fardescribed are within the contemplation of the inventors.

With reference again to FIG. 20, a detachable heater 240 may bepositioned on, or in, the wound cover 205 within the pocket formedtherein, with the opening to the pocket provided by either of the slits233. The wound cover 205, with the heater 240 contained within thepocket, is supported substantially in a plane or surface above a woundby the support member 206. The heater 240 is illustrated as beingplanar, but may comprise other shapes. Preferably, the heater 240 isconnected to and powered by a portable power supply 241. When the heater240 is received within the pocket and powered by the power supply 241,heat treatment of a wound by radiation through a treatment volume formedby the support member 206 and the wound cover 205 may be provided asdescribed above.

Referring again to FIGS. 22 and 25, first and second embodiments of thetransition portion 208 are illustrated. It is understood that theseembodiments are only representative of the general principle ofproviding a joint between the attachment portion 202 and the woundtreatment portion 204 that acts between the bottom surface of thestandoff 206 and the top surface 219 of the attach nient portion 202.FIGS. 21, 22, 24, and 25 are cross-sectional perspective views of thefirst and second embodiments taken along lines A—A of FIG. 20.

With reference to FIGS. 21 and 22, the first embodiment of a flexiblenon-contact wound treatment device with a joint acting between theattachment and wound treatment portions includes a joint embodied by thepleated member 210. The pleated member 210 is adhered, bonded, orotherwise attached along an upper edge 210 a to the bottom surface ofthe standoff 206. The pleated member 210 is attached along a lower edge210 b by adhesive, heat bonding, or other appropriate means to the topsurface 219 of the flexible attach rnent member 202. Preferably, asshown in FIG. 21, the pleated member 210 is attached to the lowersurface of the standoff 206 near an inner perimeter 228 where the lowersurface transitions to the inner surface 227. Similarly, the pleatedmember 210 is preferably attached to the upper surface 219 of theattachment portion 202 near the inner perimeter 222. This is shownclearly in FIGS. 21 and 23. Nevertheless, the pleated member 210 couldbe dimensioned to be attached between the attachment and wound treatmentportions 202 and 204 along any closed-looped trace between the lowersurface of the standoff 206 and the upper surface 219 of the attachmentportion 204. Preferably, the pleated member comprises a urethane filmwhich may be molded or extruded to form the multiple stacked pleatsshown in the figures.

Manifestly, construction details of the wound treatment device mayresult in the pleated member 210 being connected indirectly to either,or both, of the standoff and attachment portion. However, as long as thepleated member acts between these or equivalent elements in the locationshown and for the purpose described, it will meet the definition of theinvention.

As shown in FIGS. 21, 22 and 23, the flexible, non-contact woundtreatment device 200 with a transition portion 208 in the firstembodiment in the form of a pleated member 210 is suitable for placementonto a skin surface 250 so as to surround a selected wound area 252 thatabuts a treatment volume 256 enclosed or contained within the woundtreatment device 200. This attachment may be directly to the skinsurface 250, or on another member such as an ostomy ring that is, inturn, mounted or attached to the skin surface 250. As FIGS. 21 and 23illustrate, the flexible, non-contact wound treatment device 200 of thisinvention satisfies the objective previously stated by a capability ofbeing conformably attached to an uneven, changing surface supporting awound treatment portion 204 that remains reasonably or substantially inits original shape, regardless of body contour or movements. In thisregard, as FIGS. 21, 22 and 23 illustrate, the attachment portion 202operates as a flexion joint that flexes to adapt to the contour of theskin surface 252. In addition, the transition portion 208 in the form ofthe pleated member 210 supports relative movement between the attachmentand wound treatment portions 202 and 204, permitting them to move towardand away from each other, and also parallel to each other, therebyenhancing the conformability of the wound treatment device 200 tocontour and movement of the body. Relatedly, the attachment portion 202is free to conform to the shape of the skin surface 250 by flexiblydeforming between the inner and outer perimeters 222 and 223. At thesame time, the wound treatment portion 204 is relatively undeformed sothat the standoff 206 is able to support the layer 230 and stretcher 232in a predetermined orientation with respect to the wound area 252. Inthe meantime, the wound treatment device 200 forms a barrier between thewound treatment volume 256 and the ambient atmosphere by virtue of theseal between the wound cover 205 and the standoff 206, the skinned outerand lower surfaces of the standoff 206, and the seals between thepleated member 210 and the standoff 206 and attachment portion 202. Thebottom of the wound treatment device 200 is sealed to the skin 250 whenthe release layer (not shown) is peeled off so that the lower adhesivefilm layer (not shown) of the attachment portion 202 seals to the skinsurface 250.

The second embodiment of the transition portion 208 may be understoodwith reference to FIGS. 24, 25 and 26A-26C. In this regard, thetransition portion comprises a seam acting between the lower surface ofthe standoff 206 and the upper surface 219 of the attachment portion202. Three possible seam locations are shown in FIG. 25. Such a seam maybe formed by any appropriate means of attachment between the attachmentportion 202 and the lower surface of the standoff 206. Such may include,without limitation, adhesive attachment, heat bonding, or any otherappropriate measure.

As with the first embodiment of the joint, the inventors contemplatethat a seam may be placed between other elements that effectivelyconnect the seam to the attachment portion 202 and the lower surface ofthe standoff 206 in the location shown and for the purposes described.

The second embodiment of the transition portion 208 effectively allowsarticulation between the attachment portion 202 and the wound treatmentportion 204. This is shown clearly in FIGS. 24 and 26A-26C. For example,in FIGS. 24 and 26B, the seal is in the location indicated by 208/220 inFIG. 25, essentially sealing an outer periphery of the upper surface 219near the outer perimeter 223 to a corresponding outer periphery of thelower surface of the standoff 206. This permits the section ofattachment portion 202 extending to the inner perimeter 222 toarticulate toward or away from the lower surface of the stand off 206.FIG. 26A shows attachment of the attachment portion 202 along the seam208/222 to the lower surface of the standoff 206 near the innerperimeter 222, where the section of the attachment portion 202 extendingto the outer perimeter 223 can articulate toward or away from the lowersurface of the standoff 206. FIG. 26C shows attachment of the uppersurface 219 to the lower surface of the standoff 206 along the seam208/221. In this location, the seam permits articulation of multiplesections of the attachment portion 202.

The third embodiment of the transition portion 208 may be understoodwith reference to FIGS. 2-29. In these figures, the transition portioncomprises a bridge of foam material spanning and providing a narrowpassage through the space between the bottom surface of the standoff 206and the top surface 219 of the attachment portion 202. The bridge 209 isprovided during the manufacture of the standoff 206 and the attachmentportion 202 as an integrated, unitary piece by, for example, moldingopen-celled plastic foam of the self-skinning type. In this case, thebridge 209 is provided for in the mold and forms concurrently andintegrally with the standoff 206 and the attachment portion 202. Aftermolding, an adhesive fil m layer with an attached release liner 112, 113(both described above with respect to the wound treatment deviceillustrated in FIGS. 15-17) may be attached to the lower surface of theattachment portion for application of the wound treatment device to askin surface. Manifestly, the bridge 209 may be selectively locatedbetween the inner and outer perimeters 222 and 223 of the attachmentportion 202 as with the first and second embodiments described above. Inall other respects, the wound treatment device of FIGS. 27-29 issubstantially identical with the wound treatment devices in FIGS.20-26C.

As with the second embodiment, the bridge 209 effectively allowsarticulation between the attachment portion 202 and the wound treatmentportion 204.

Three significant advantages result from placement of a joint beneaththe standoff 206 of the wound treatment portion 204.

First, in plan, the shapes and extents of the bottom surface of thestandoff 206 and the attachment portion 202 align and largely overlap,thereby reducing the “footprint” of the wound treatment device 200 to asingle, substantially annular shape (which may be many-sided orcircular), from the concentric shapes of FIGS. 2 and 3.

Next, the joint acting between the lower surface of the standoff 206 andthe upper surface 219 of the attachment portion 202 increasesconformability of the wound treatment device 200 to shape and movement,while maintaining the predetermined shape of the wound cover 205 andpreventing its contact with the wound.

Last, the joint acting between the lower surface of the standoff 206 andthe upper surface 219 of the attachment portion 202 forms a barrier tomoisture and wound exudate which may be absorbed by the inner surface227 of the standoff 206, thereby reducing maceration of the skinunderneath the attachment portion 202.

While the invention has been illustrated by means of specificembodiments and examples of use, it will be evident to those skilled inthe art that many variations and modifications may be made thereinwithout deviating from the scope and spirit of the invention. However,it is to be understood that the scope of the present invention is to belimited only by the appended claims.

What is claimed is:
 1. A non-contact wound treatment device, comprising:a flexible attachment portion having an opening defined by a closedperimeter; a support member having an opening; the attachment portionand support member openings aligned to form a wound treatment volume;and a joint connecting the support member and attachment portion; andthe joint positioned between a surface of the support member and asurface of the attachment portion that overlaps and faces the surface ofthe support member, the joint permitting relative movement between thesupport member and the attachment portion.
 2. The non-contact woundtreatment device of claim 1, wherein the joint comprises a pleatedmember attached to the surface of the support member and to the surfaceof the attachment portion.
 3. The non-contact wound treatment device ofclaim 1, wherein the joint comprises a seam between the surface of thesupport member and the surface of the attachment portion.
 4. Thenon-contact wound treatment device of claim 1, wherein the jointcomprises a bridge of material between the surface of the support memberand the surface of the attachment portion.
 5. The non-contact woundtreatment device of claim 1, wherein the support member and theattachment portion are annular.
 6. The non-contact wound treatmentdevice of claim 1, further including a wound cover on the supportmember, over the opening in the support member.
 7. The non-contact woundtreatment device of claim 6, further including a heater.
 8. Thenon-contact wound treatment device of claim 7, wherein the wound coverand heater are substantially planar.
 9. The non-contact wound treatmentdevice of claim 8, wherein the joint comprises a pleated member.
 10. Thenon-contact wound treatment device of claim 8, wherein the jointcomprises a seam.
 11. The non-contact wound treatment device of claim 8,wherein the joint comprises a bridge of material.
 12. The non-contactwound treatment device of claim 1, wherein the surface of the supportmember is a lower surface and the surface of the attachment member is anupper surface.